• Quality Assurance Manager

    Posted Date 4 months ago(8/9/2018 1:57 PM)
    Job ID
    2018-3098
    # of Openings
    1
    Job Location(s)
    US-MD-Bethesda
    Category
    Science
  • Overview

    Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

     

    We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

     

    Duties & Responsibilities

    Medical Science & Computing is searching for a Quality Assurance Manager  to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on site in Bethesda, MD.

     

    • Assist in providing regulatory guidance and QA/compliance support for manufacturing of, and clinical research with, investigational drugs, biologics or devices for use in clinical studies (i.e., pharmacy/pharmaceutical compounding, manufacturing and clinical research).
    • Responsible for drafting and reviewing filings and responses for the Food and Drug Administration and others agencies or entities involved in oversight of clinical research.
    • Attend meetings with other staff to represent NIH in developing strategies for engaging and responding to concerns of these authorities, including the planning and execution of such negotiations.
    • Review documents for completeness; and provides essential information for specialists and researchers; track and monitor assigned projects.
    • Utilize scientific knowledge to prepare guidance, regulatory filings, audits, and other documents to support research activities within the NIH Office of the Director and NIH Institutes and Centers.
    • Assist with educational programs designed to train scientific and administrative staff about regulatory affairs issues such as cGMP and GCP standards, rules for research with IND, IND exempt research, IDE and other FDA-regulated research, other applicable federal and international requirements and standards, privacy of confidential information and data and handling of research materials.
    • Assess the regulatory affairs and quality assurance risks of proposed or ongoing research activities through a thorough review of information from investigators, research support staff, research sponsors, companies (where applicable), and publicly available materials.
    • Provide the initial review of inquiries from investigators, research support staff, and research sponsors, analyzes regulatory affairs and quality assurance issues, and uses knowledge, gleaned from research of appropriate internal and external requirements and databases to develop appropriate risk management strategies.
    • Liaison and handle inquiries to NIH investigators, research support staff, research sponsors, and companies (where applicable), related to research activities to develop tailored and general guidance to ensure regulatory compliance.
    • Advise on the impact of changes in mission or resources and recommends alternative courses of action and possible solutions for resolving management problems in areas such as systems, manpower utilization, productivity management, workflow, and paperwork management.
    • Gather statistical information using, and when necessary modifying, accepted methods to suit the peculiar circumstances presented by different studies and projects; such as statistical analysis of information systems; the review of progress reports; acquisition of information from personnel documents, budget reports, and past management studies; discussions and interviews with managers and workers; and the conduct of special inquiries.
    • Analyze and prepare program status reports for review; recommendations for effective organizational changes to promote efficiency and cost savings.
    • Perform program cost analyses such as development of life cycle or other cost analyses of projects, or performance of cost benefit or economic evaluations of programs.
    • Develop various statistical tables and reports, new or modified work methods, management processes and procedures for administering program services, guidelines and procedures for program operations, and the effectiveness of programs or grant operations in meeting established goals and objectives.
    • Perform other duties as needed.

    Requirements

    • BS degree with 5+ years of relevant experience; MS degree with 3 years.
    • Extensive experience supporting clinical trials.
    • Thorough knowledge of ICH Guidelines, GxP and related regulatory guidances.
    • Proven track record of building and maintaining strong relationships with internal and external stakeholders.
    • Ability to manage deadlines and prioritize effectively, while maintaining flexibility.
    • Track record of effective business process improvements and systems implementation, including strong change management skills.
    • Excellent communication and interpersonal skills; able to communicate with variety of audiences and collaborate effectively with a variety of internal and external stakeholders.
    • Pragmatic and strategic thinker who meets objectives and leads by example.
    • Quality professional certification preferred, especially CQA.

    Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

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